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September 20, 2015
20
Sep

FDA CDRH Learn HealthIT and Cybersecurity Modules

September 20, 2015
FDA maintains a webpage for its educational modules referred to as “CDRH Learn.”  Specialty Technical Topics provides a list with a section for IT and Software that includes three modules on Digital Health, Cybersecurity information in premarket submissions, and CDRH regulated software.
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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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